Senior Specialist, Cell Therapy Vein-to-Vein Process Excellence & Quality Operations

AstraZeneca plc; Gaithersburg (MD); On-site; USD 89,000 - 134,000; Full time

Benefits offered by this job

Long-term incentives

Retirement plan

Job summary

AstraZeneca Cell Therapy in Gaithersburg seeks a Senior Specialist, Cell Therapy V2V Process Excellence & Quality Operations to drive end-to-end Vein-to-Vein processes across patient and product journeys, translating operating models into workflows, documentation, and measurable improvements.

You will partner with Quality, Manufacturing, Clinical Operations, Digital, and external partners to map processes, embed GxP requirements, lead CAPA analyses, manage deviations, and support

Qualifications

• 5+ years of experience in biopharma, cell therapy, pharma supply chain, quality operations, process excellence, or another regulated environment.
• Experience mapping processes, optimizing processes, root-cause analysis, deviation and CAPA support, risk assessments, or continuous improvement.
• Working knowledge of GMP, GDP, GxP, controlled documentation, and inspection-readiness requirements.

Responsibilities

• Implement and continuously improve end-to-end Vein-to-Vein processes across the patient and product journey in line with process standards.
• Develop and maintain process maps, business rules, SOPs, and work instructions.
• Embed GxP, GDP, quality-by-design, and inspection-readiness into V2V processes and documentation.
• Partner with Quality and operations on deviation investigations, root-cause analysis, CAPA development and implementation, change controls, risk assessments, and effectiveness checks.
• Analyze deviations, exceptions, handoff failures, and trends; identify systemic gaps and propose improvements.
• Maintain and improve controls for Chain of Identity and Chain of Custody, with defined handoffs and escalation paths.
• Conduct readiness and gap assessments for new products, sites, countries, lanes, and service models; track actions to closure.
• Support clinical-to-commercial transition and launch readiness with established processes, documentation, training, and escalation mechanisms.
• Collaborate with Digital to translate process needs into requirements and support testing, deployment and adoption of V2V capabilities.
• Promote a patient-centered quality culture with proactive risk identification and escalation.

Skills

Analytical skills

Problem solving

Communication

Stakeholder management

Independent work

Education

Bachelor's degree in supply chain or related field

Tools

Excel

Power BI

Visio

Smartsheet

Job description

At AstraZeneca Cell Therapy, we are building the capabilities required to deliver complex, personalized therapies through a highly coordinated, patient-centered operating model. As we strengthen our Vein-to-Vein Operations, we are increasing our focus on standardized execution, patient and product traceability, proactive exception management, operational performance, and quality.

The Senior Specialist, Cell Therapy V2V Process Excellence & Quality Operations will support the implementation, standardization, and continuous improvement of scalable Vein-to-Vein processes across the patient and product journey. The role will translate approved operating models and process standards into practical workflows, controlled documentation, performance measures, and improvement initiatives that enable consistent, compliant, and inspection-ready execution. Working across Vein-to-Vein Operations, Quality, Manufacturing, Clinical Operations, Digital, Trade Compliance, treatment sites, and external logistics partners, you will identify process gaps, strengthen operational controls, and support clinical-to-commercial growth.

Accountabilities

• Implement and continuously improve assigned end-to-end Vein-to-Vein processes across the patient and product journey, in alignment with approved process standards and governance.

• Develop and maintain clear, controlled process maps, business rules, playbooks, templates, decision trees, RACIs, SOPs, and work instructions.

• Embed GxP, GDP, quality-by-design, and inspection-readiness expectations into V2V operational processes and documentation.

• Partner with Quality and operational stakeholders on deviation investigations, root-cause analysis, CAPA development and implementation, change controls, risk assessments, and effectiveness checks, within assigned responsibilities.

• Analyze recurring deviations, exceptions, handoff failures, and operational trends; distinguish isolated execution issues from systemic process gaps; and recommend sustainable improvements.

• Maintain and improve operational controls that protect Chain of Identity and Chain of Custody, including defined handoffs, verification points, escalation pathways, and exception-management requirements.

• Conduct documented process-readiness and gap assessments for new products, treatment sites, countries, logistics lanes, and service models, and track identified actions to closure.

• Support clinical-to-commercial transition and launch readiness by ensuring processes, documentation, training, quality controls, and escalation mechanisms are established and operationally executable.

• Partner with Digital and business stakeholders to translate process needs into business requirements and support testing, deployment, and adoption of V2V capabilities.

• Promote a patient-centered quality culture in which risks and potential issues are identified, escalated, and addressed proactively.

Essential Skills/Experience

• Bachelor's degree in supply chain or a related field.

• At least 5 years of relevant experience in biopharma, cell therapy, pharmaceutical supply chain, quality operations, process excellence, or another regulated operational environment.

• Demonstrated experience in process mapping, process optimization, structured root-cause analysis, deviation and CAPA support, risk assessment, or continuous improvement.

• Working knowledge of GMP, GDP, GxP, controlled documentation, and inspection-readiness requirements.

• Experience translating complex operational requirements into clear processes, standards, procedures, and business requirements.

• Strong analytical, problem-solving, facilitation, communication, and stakeholder-management skills.

• Ability to work independently, manage multiple priorities, and influence Operations, Quality, Digital, Manufacturing, Clinical, and external partners in a matrix environment.

Desirable Skills/Experience

• Experience in cell therapy, autologous supply chain, personalized medicine, or another patient-specific operating model.

• Knowledge of patient and order orchestration, cold-chain logistics, and COI/COC traceability.

• Experience supporting commercial launch readiness, clinical-to-commercial transition, or global network expansion.

• Lean or Six Sigma training or certification.

• Experience with FMEA, process governance, SOP/WI frameworks, digital capability deployment, and process-controlled change.

• Experience with Excel, Power BI, Visio, Smartsheet, or similar process and analytics tools.

#CellTherapy

The annual base pay for this position ranges from $89K to $134K. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. *This position does not offer visa sponsorship.

Date Posted

03-Nov-2026

Closing Date

10-Nov-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.